open access
Prognostic value of post-procedural μQFR for drug-coated balloons in the treatment of in-stent restenosis
, 1, 1, 1, 1, 1, 1, 1, 2, 1
Affiliations- Department of Cardiovascular Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China
open access
Abstract
Background: Investigating the prognostic value of the Murray law-based quantitative flow ratio
(μQFR) on the clinical outcome after treatment of in-stent restenosis (ISR) with a drug-coated balloon
(DCB).
Methods: Patients participating in a previous randomized clinical trial for DCB-ISR were post-hoc
analyzed. The primary endpoint was vessel-oriented composite endpoint (VOCE), defined as cardiac
death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
μQFRs at baseline and after DCB angioplasty was calculated, and its prognostic value as a predictor
of VOCE was explored in Cox regression.
Results: A total of 169 lesions in 169 patients were analyzed. At 1-year follow-up, 20 VOCEs occurred
in 20 patients. Receiver-operating characteristic curve analysis identified a post-procedural μQFR of
≤ 0.89 as the best cut-off to predict VOCE (area under curve [AUC]: 0.74; 95% confidence interval [CI]:
0.67–0.80; p < 0.001), superior to post-procedural in-stent percent diameter stenosis, which reported an
AUC of 0.61 (95% CI: 0.53–0.68; p = 0.18). Post-procedural μQFR was significantly lower in patients
with VOCE compared with those without (0.88 [interquartile range: 0.79–0.94] vs. 0.96 [interquartile
range: 0.91–0.98], respectively; p < 0.001). After correction for potential confounders, post-procedural
μQFR ≤ 0.89 was associated with a 6-fold higher risk of VOCE than lesions with μQFR > 0.89 (hazard
ratio: 5.94; 95% CI: 2.33–15.09; p < 0.001).
Conclusions: Post-procedural μQFR may become a promising predictor of clinical outcome after treatment
of DES-ISR lesions by DCB angioplasty.
Abstract
Background: Investigating the prognostic value of the Murray law-based quantitative flow ratio
(μQFR) on the clinical outcome after treatment of in-stent restenosis (ISR) with a drug-coated balloon
(DCB).
Methods: Patients participating in a previous randomized clinical trial for DCB-ISR were post-hoc
analyzed. The primary endpoint was vessel-oriented composite endpoint (VOCE), defined as cardiac
death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
μQFRs at baseline and after DCB angioplasty was calculated, and its prognostic value as a predictor
of VOCE was explored in Cox regression.
Results: A total of 169 lesions in 169 patients were analyzed. At 1-year follow-up, 20 VOCEs occurred
in 20 patients. Receiver-operating characteristic curve analysis identified a post-procedural μQFR of
≤ 0.89 as the best cut-off to predict VOCE (area under curve [AUC]: 0.74; 95% confidence interval [CI]:
0.67–0.80; p < 0.001), superior to post-procedural in-stent percent diameter stenosis, which reported an
AUC of 0.61 (95% CI: 0.53–0.68; p = 0.18). Post-procedural μQFR was significantly lower in patients
with VOCE compared with those without (0.88 [interquartile range: 0.79–0.94] vs. 0.96 [interquartile
range: 0.91–0.98], respectively; p < 0.001). After correction for potential confounders, post-procedural
μQFR ≤ 0.89 was associated with a 6-fold higher risk of VOCE than lesions with μQFR > 0.89 (hazard
ratio: 5.94; 95% CI: 2.33–15.09; p < 0.001).
Conclusions: Post-procedural μQFR may become a promising predictor of clinical outcome after treatment
of DES-ISR lesions by DCB angioplasty.
Keywords
quantitative flow ratio, drug-coated balloon, in-stent restenosis
About this articleTitle
Prognostic value of post-procedural μQFR for drug-coated balloons in the treatment of in-stent restenosis
Journal
Issue
Article type
Original Article
Pages
167-177
Published online
2021-11-19
Page views
3114
Article views/downloads
791
DOI
Pubmed
Bibliographic record
Cardiol J 2023;30(2):167-177.
Keywords
quantitative flow ratio
drug-coated balloon
in-stent restenosis
Authors
Lili Liu
Fenghua Ding
Juan Luis Gutiérrez-Chico
Jinzhou Zhu
Zhengbin Zhu
Run Du
Zhenkun Yang
Jian Hu
Shengxian Tu
Ruiyan Zhang
References (36)- Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007; 370(9591): 937–948.
- Stone G, Moses J, Ellis S, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007; 356(10): 998–1008.
- Dangas GD, Claessen BE, Caixeta A, et al. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010; 56(23): 1897–1907.
- Alfonso F, Byrne RA, Rivero F, et al. Current treatment of in-stent restenosis. J Am Coll Cardiol. 2014; 63(24): 2659–2673.
- Scheller B, Clever YP, Kelsch B, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006; 355(20): 2113–2124.
- Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009; 119(23): 2986–2994.
- Adriaenssens T, Dens Jo, Ughi G, et al. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial. EuroIntervention. 2014; 10(4): 439–448.
- Pleva L, Kukla P, Kusnierova P, et al. Comparison of the efficacy of paclitaxel-eluting balloon catheters and everolimus-eluting stents in the treatment of coronary in-stent restenosis: the treatment of in-stent restenosis study. Circ Cardiovasc Interv. 2016; 9(4): e003316.
- Giacoppo D, Matsuda Y, Fovino LN, et al. Short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy vs. prolonged dual antiplatelet therapy after percutaneous coronary intervention with second-generation drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials. Eur Heart J. 2021; 42(4): 308–319.
- Chen Y, Gao L, Qin Q, et al. Comparison of 2 different drug-coated balloons in in-stent restenosis: the RESTORE ISR China randomized trial. JACC Cardiovasc Interv. 2018; 11(23): 2368–2377.
- Zhu J, Liu L, Zhu Z, et al. A randomized comparison of a novel iopromide-based paclitaxel-coated balloon Shenqi versus SeQuent Please for the treatment of in-stent restenosis. Coron Artery Dis. 2021; 32(6): 526–533.
- Xu Bo, Gao R, Wang J, et al. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014; 7(2): 204–211.
- Giacoppo D, Alfonso F, Xu Bo, et al. Drug-Coated balloon angioplasty versus drug-eluting stent implantation in patients with coronary stent restenosis. J Am Coll Cardiol. 2020; 75(21): 2664–2678.
- Tu S, Barbato E, Köszegi Z, et al. Fractional flow reserve calculation from 3-dimensional quantitative coronary angiography and TIMI frame count: a fast computer model to quantify the functional significance of moderately obstructed coronary arteries. JACC Cardiovasc Interv. 2014; 7(7): 768–777.
- Xu Bo, Tu S, Qiao S, et al. Diagnostic accuracy of angiography-based quantitative flow ratio measurements for online assessment of coronary stenosis. J Am Coll Cardiol. 2017; 70(25): 3077–3087.
- Tu S, Westra J, Yang J, et al. Diagnostic accuracy of fast computational approaches to derive fractional flow reserve from diagnostic coronary angiography: the international multicenter FAVOR pilot study. JACC Cardiovasc Interv. 2016; 9(19): 2024–2035.
- Asano T, Katagiri Y, Collet C, et al. Functional comparison between the BuMA Supreme biodegradable polymer sirolimus-eluting stent and a durable polymer zotarolimus-eluting coronary stent using quantitative flow ratio: PIONEER QFR substudy. EuroIntervention. 2018; 14(5): e570–e579.
- Liontou C, Mejía-Rentería H, Lauri F, et al. Quantitative flow ratio for functional evaluation of in-stent restenosis. EuroIntervention. 2021; 17(5): e396–e398.
- Biscaglia S, Tebaldi M, Brugaletta S, et al. Prognostic value of QFR measured immediately after successful stent implantation: the international multicenter prospective HAWKEYE study. JACC Cardiovasc Interv. 2019; 12(20): 2079–2088.
- Cai X, Tian F, Jing J, et al. Prognostic value of quantitative flow ratio measured immediately after drug-coated balloon angioplasty for in-stent restenosis. Catheter Cardiovasc Interv. 2021; 97 Suppl 2: 1048–1054.
- Tang J, Hou H, Chu J, et al. Clinical implication of quantitative flow ratio to predict clinical events after drug-coated balloon angioplasty in patients with in-stent restenosis. Clin Cardiol. 2021; 44(7): 978–986.
- Tu S, Ding D, Chang Y, et al. Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: A novel method based on bifurcation fractal law. Catheter Cardiovasc Interv. 2021; 97 Suppl 2: 1040–1047.
- Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999; 100(18): 1872–1878.
- Meijboom WB, Van Mieghem CAG, van Pelt N, et al. Comprehensive assessment of coronary artery stenoses: computed tomography coronary angiography versus conventional coronary angiography and correlation with fractional flow reserve in patients with stable angina. J Am Coll Cardiol. 2008; 52(8): 636–643.
- Toth G, Hamilos M, Pyxaras S, et al. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014; 35(40): 2831–2838.
- Nunen Lv, Zimmermann F, Tonino P, et al. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. 2015; 386(10006): 1853–1860.
- Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011; 124(23): 2574–2609.
- NEUMANN FJ, SOUSA-UVA M, AHLSSON A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019; 40(2): 87–165.
- Ding D, Huang J, Westra J, et al. Immediate post-procedural functional assessment of percutaneous coronary intervention: current evidence and future directions. Eur Heart J. 2021; 42(27): 2695–2707.
- Gutiérrez-Chico JL, Chen Y, Yu W, et al. Diagnostic accuracy and reproducibility of optical flow ratio for functional evaluation of coronary stenosis in a prospective series. Cardiol J. 2020; 27(4): 350–361.
- Bech GJ, Pijls NH, De Bruyne B, et al. Usefulness of fractional flow reserve to predict clinical outcome after balloon angioplasty. Circulation. 1999; 99(7): 883–888.
- Lee JM, Hwang D, Choi KiH, et al. Prognostic impact of residual anatomic disease burden after functionally complete revascularization. Circ Cardiovasc Interv. 2020; 13(9): e009232.
- Yerasi C, Case BC, Forrestal BJ, et al. Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol. 2020; 75(9): 1061–1073.
- Kedhi E, Berta B, Roleder T, et al. Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial. Eur Heart J. 2021 [Epub ahead of print].
- Yang ZK, Shen Y, Dai Y, et al. Impact of coronary collateralization on long-term clinical outcomes in type 2 diabetic patients after successful recanalization of chronic total occlusion. Cardiovasc Diabetol. 2020; 19(1): 59.
- Shi R, Shi Ke, Yang ZG, et al. Serial coronary computed tomography angiography-verified coronary plaque progression: comparison of stented patients with or without diabetes. Cardiovasc Diabetol. 2019; 18(1): 123.
